USP <800> Brings Change, Collaboration to Pharmacy and Nursing

September 03, 2019 by Chris Pirschel ONS Staff Writer/Producer
linsey amerine
Lindsey Amerine, PharmD, MS, BCPS, is the interim regional director of pharmacy at at the University of North Carolina Medical Center and the interim executive associate dean and associate professor of clinical education at the UNC Eshelman School of Pha

U.S. Pharmacopeia (USP) chapter <800> provides safety measures for all healthcare workers in any setting where hazardous drugs (HDs) are used in the health system. For situations from the initial delivery of the drug to the institution through administration and disposal, USP <800> provides a vast number of safety measures intended to minimize risk and potential exposure to HDs. To meet the new requirements, medical institutions and pharmacies have had to make significant changes in various systems.

From a pharmacy perspective, several changes may affect practice. Most notably, many facilities’ physical space must be updated to meet the USP standards, including redesigning a pharmacy’s layout to ensure HDs are handled correctly and stored separately from other nonhazardous drugs. Previous USP chapters offered exemptions to institutions that provide low volumes of HDs, allowing them to prepare HDs in the normal area for compounding. That’s no longer the case with USP <800>. Facilities must use a negative pressure space to compound HDs and follow garbing and gowning protocols. Other changes involve receipt of drugs from the wholesaler, how damaged HDs are inspected at delivery, and how pharmacies are ventilated.  

Currently, University of North Carolina pharmacy professionals are enrolled in several online learning modules to understand and prepare for the changes in practice after USP <800> is implemented in December 2019. The university has also contracted a third party to help with standard competencies, including USP <800>, which is part of the education process for pharmacy professionals. Also, professional organizations like the American Society of Health-System Pharmacists have developed educational resources for pharmacy staff. Ultimately, connecting staff to online resources and education modules has helped provide a comprehensive overview of incoming changes to our pharmacy—not just for USP <800> but also for new changes to chapter <797> for sterile compounding. 

Understanding the science behind the USP <800> changes can help providers contextualize the importance of new practice procedures and why they’re recommended. For oncology nurses in particular, the introduction of closed-system transfer devices (CSTDs) has led to lower exposure risks in several studies. But it’s important for nurses to understand the science behind CSTD benefits—and limitations—to recognize the reasons for their use in practice. 

For many institutions, changes to meet USP <800> compliance likely began more than three years ago. Meeting new standards for safe handling provides opportunities for collaboration and teamwork among healthcare professionals. Oncology nurses, pharmacists, physicians, housekeeping staff, infection control professionals, and engineering staff are working together to implement changes from USP <800>. Because safe handling and potential HD exposure can affect all levels of healthcare staff, it’s crucial to have all parties at the table when discussing and implementing potential workflow changes. 

As USP <800> standards are brought into practice, pharmacy and nursing professionals can collaborate to develop research studies examining their impact on practice safety for patients and healthcare workers. Long-term studies will be needed to understand which changes have worked, what needs to be revamped, and what gaps still exist.


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